READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE PATIENT MEDICATION INFORMATION A Notice of Compliance with Conditions (NOC/c) is a type of approval to sell a drug in Canada. IBRANCE is used: -along with the medicine letrozole to treat breast cancer that has spread to other parts of the body. It is used in postmenopausal women to treat certain types of breast cancers that are estrogen receptor positive. It has been approved with conditions. This means it has passed Health Canada s review and can be bought and sold in Canada, but the manufacturer has agreed to complete more studies to make sure the drug works the way it should. For more information, talk to your healthcare professional. What is a Notice of Compliance with Conditions (NOC/c)? Health Canada only gives an NOC/c to a drug that treats, prevents, or helps identify a serious or life-threatening illness. The drug must show promising proof that it works well, is of high quality, and is reasonably safe. Also, the drug must either respond to a serious medical need in Canada, or be much safer than existing treatments. Drug makers must agree in writing to clearly state on the label that the drug was given an NOC/c, to complete more testing to make sure the drug works the way it should, to actively monitor the drug s performance after it has been sold, and to report their findings to Health Canada. IBRANCE Product Monograph Page 30 of 35
Pr IBRANCE Palbociclib Capsules Read this carefully before you start taking IBRANCE and each time you get a refill. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about IBRANCE. Your breast cancer will be treated with IBRANCE in combination with letrozole. Read the letrozole Patient Medication Information leaflet carefully as well as this one. Serious Warnings and Precautions Take IBRANCE under the care of a doctor who knows how to use anti-cancer drugs. IBRANCE may cause the number of white blood cells in your blood to be abnormally low. What is IBRANCE used for? IBRANCE is a prescription medicine that is used along with the medicine letrozole to treat breast cancer that has spread to other parts of the body. It is used in postmenopausal women to treat certain types of breast cancers that are estrogen receptor positive. How does IBRANCE work? Palbociclib belongs to a family of medications called kinase inhibitors. These medications work by stopping cancer cells from dividing and growing. When given together with letrozole, IBRANCE may slow down the growth and spread of breast cancer cells What are the ingredients in IBRANCE? Medicinal ingredients: Palbociclib Non-medicinal ingredients: ammonium hydroxide, colloidal silicon dioxide, gelatin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol, red iron oxide, shellac, simethicone, sodium starch glycolate, titanium dioxide, and yellow iron oxide. IBRANCE comes in the following dosage forms: Capsules: 75 mg, 100 mg and 125 mg Do not use IBRANCE if: You are allergic to palbociclib or any of the other ingredients of IBRANCE. To help avoid side effects and ensure proper use, talk to your healthcare professional before you take IBRANCE. Talk about any health conditions or problems you may have, including if you: Have fever, chills, or any other signs or symptoms of infection IBRANCE Product Monograph Page 31 of 35
Have heart problems, including a condition called long QT syndrome. Have liver or kidney problems. Have any other medical conditions. Are pregnant, or plan to become pregnant. IBRANCE may harm your unborn baby. Are a woman who is able to become pregnant. IBRANCE is recommended for use only in women who are postmenopausal and thus unable to become pregnant. If you are able to become pregnant and are taking IBRANCE, you should use birth control during treatment and for at least 21 days after stopping IBRANCE. Talk to your doctor about the birth control methods that may be right for you. If you become pregnant, tell your doctor right away. Are breastfeeding or plan to breastfeed. It is not known if IBRANCE passes into breast milk. You and your doctor should decide if you will take IBRANCE or breastfeed. You should not do both. Other warnings you should know about: IBRANCE may cause: Serious or life-threatening infections. Your doctor will decide when to perform blood tests and will interpret the results. Tell your doctor right away if you have fever, chills, or any other signs or symptoms of infection. Pulmonary embolism (a blockage in the lungs). Neutropenia and Leukopenia (low white blood cells) Anemia (low red blood cells) IBRANCE should not be used in children and adolescents under 18 years of age. Driving and using machines: Fatigue and dizziness can occur with IBRANCE. Be careful when driving or operating machinery while you are taking IBRANCE. Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines. Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine. The following may interact with IBRANCE: Medicines for infections (antibiotics), such as clarithromycin, nafcillin, rifampin and telithromycin Medicines for fungal infections, such as ketoconazole, itraconazole, posaconazole and voriconazole Some medicines for high blood pressure, such as bosentan HIV medicines, such as saquinavir, ritonavir, indinavir, nelfinavir, lopinavir, efavirenz and etravirine Antiviral medicines, such as telaprevir Antidepressant medicines, such as nefazodone Medicines to treat epilepsy, such as carbamazepine and phenytoin IBRANCE Product Monograph Page 32 of 35
Medicines to treat certain types of sleep disorders, such as modafinil St. John s wort Do not drink grapefruit juice or eat grapefruit, or products containing grapefruit extracts, star fruit, pomegranate, Seville oranges or other similar fruits. They may change the amount of IBRANCE in your body. Other drugs not listed here may also interact How to take IBRANCE: Take IBRANCE exactly as your doctor tells you. Swallow IBRANCE capsules whole. Do NOT crush, dissolve or open the capsules. You should take IBRANCE with food once daily for 21 days. This is followed by 7 days off (3 weeks on, 1 week off) for a 28 day cycle. Take IBRANCE at approximately the same time each day. If you vomit after taking a dose of IBRANCE, do not take an extra dose. Take your next dose at your regular time. Recommended starting dosage strength: 125 mg Usual Adult dose: 1 capsule once a day with food for 21 days. Overdose: If you think you have taken too much IBRANCE contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. Missed Dose: If you miss a day s dose, do not take an extra dose the next day. Take your next dose at your regular time. What are possible side effects from using IBRANCE? These are not all the possible side effects you may feel when taking IBRANCE. If you experience any of these side effects or side effects not listed here, contact your healthcare professional. Please also see the Serious Warnings and Precautions Box. Side effects may include: Decrease in the number of white blood cell, red blood cell and platelet counts in the bloodstream Shortness of breath IBRANCE Product Monograph Page 33 of 35
Tiredness or weakness Cough Mouth sores Unusual hair thinning or loss Nausea, vomiting Bruising Loss of appetite Tingling or abnormal feeling (especially in arms and legs) Nose bleed Serious side effects and what to do about them Talk to your healthcare professional Symptom / effect Only if severe In all cases VERY COMMON Neutropenia and Leukopenia: infection, fever Infections:, fever, chills, dizziness, weakness, shortness of breath Anemia: fatigue, loss of energy, weakness, shortness of breath COMMON Increased tendency to bruise or bleed Diarrhea Fever Pulmonary embolism: sudden shortness of breath, chest pain and cough. Stop taking drug and get immediate medical help If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional. IBRANCE Product Monograph Page 34 of 35
Reporting Side Effects You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report: Online at MedEffect; By calling 1-866-234-2345 (toll-free); By completing a Patient Side Effect Reporting Form and sending it by: - Fax to 1-866-678-6789 (toll-free), or - Mail to: Canada Vigilance Program Health Canada, Postal Locator 0701E Ottawa, ON K1A 0K9 Postage paid labels and the Patient Side Effect Reporting Form are available at MedEffect. NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. Storage: Store IBRANCE at room temperature between 20 C to 25 C; excursions permitted between 15 C to 30 C. Keep out of reach and sight of children. If you want more information about IBRANCE: Talk to your healthcare professional Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer s website http://www.pfizer.ca, or by calling 1-800-463-6001. This leaflet was prepared by Pfizer Canada Inc. Last Revised 15 March 2016 IBRANCE Product Monograph Page 35 of 35